An Open-Label Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection

• Status: Withdrawn
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Over the years, it has become clear that the first-line triple therapy is losing efficacy worldwide. A capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg bismuth subcitrate potassium, and 125mg tetracycline was made available.

The efficacy of the Pylera capsule was studied in a randomized control trial, in which a quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard triple regimen. In the study, 3 three-in-one capsules were taken four times daily (after meals and at bedtime).

Given the above, we aim at assessing the effectiveness of fewer pills per day of the Pylera capsule (3 Pylera capsules supplemented with the addition of amoxicillin and esomeprazole twice daily; sum of 10 pills/day for 10 days) in the eradication of H. pylori.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Amoxicillin; Esomeprazole

Criteria

Inclusion Criteria:

Patients with either positive CLO tests, urea breath tests, or histopathologic documention of H. pylori infection, and agreeing to the study by signing the informed consent.

Exclusion Criteria:

• Age under 18 or older than 80 years

• Allergies to any of the drugs used

• Recent antibiotic therapy (within 2 weeks of enrollement)

• Severe ulcers or bleeding

• Gastric perforation or obstruction

• Previous gastrectomy

• Gastric cancer

• Pregnancy or lactation

• Prior eradication therapy for H. pylori

• Severe concomitant disease or condition making the treatment unlikely to be effective i.e. alcoholism, drug addiction, and history of poor compliance.